None listed
Conditions
Interventions
Intervention1: G-CSF (BioGenomics Ltd.): G-CSF 300 mcg/0.5 mL Prefilled Syringe for Subcutaneous route
Dose - 0.5 mcg/kg/day once daily for 5 days
Control Intervention1: Neupogen®: Neupogen® 300 mc
Sponsors
BioGenomics Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Willingness to provide informed consent to participate in the study. 2. Body Mass Index (BMI) between 18.0 kg/m2 to 27.0 kg/m2 (both inclusive) with minimum weight of 50 kg. 3. Nonalcoholic, nonsmoker, healthy, adult, human male volunteers of any race within the age range of 18 to 45 years (both inclusive)living in and around Ahmedabad city or Western part of India. 4. No history of any major illness in the past or absence of clinically significant abnormal findings in physical examination, laboratory evaluations, 12-lead Electrocardiogram (ECG) and X-ray chest Postero-anterior (PA) view during screening. 5. Hemoglobin: >=12.0 gm%. 6. Subjects without any evidence of impaired glucose tolerance in 2 hour Oral Glucose Tolerance Test (OGTT) at screening. 7. Absence of disease markers of HIV I & II, a negative P24 antigen test, negative Hepatitis B Surface Antigen (HBsAg) and Hepatitis C Virus Antibody (HCVAb). 8. Comprehension of the nature and purpose of the study and willingness to comply with the requirements of the entire procedure. 9. Negative breath alcohol test at every check-in. 10. Negative urine drug abuse test (barbiturates, benzodiazepines, opioids, cocaine, cannabinoids and amphetamine, etc.) at every check-in. (This test will be done at the clinical facility). Exclusion Criteria 1. History / evidence of allergy or hypersensitivity to any drug 2. Any major illness in the last three months or any significant ongoing chronic medical illness 3. Recent history or presence of active kidney or liver dysfunction. 4. Active deep vein thrombosis, pulmonary embolism, arterial thromboembolic disorders or a history of these conditions. 5. History of or current gastrointestinal diseases influencing drug absorption 6. History of drug abuse (including barbiturates, benzodiazepines, opioids, cocaine, cannabinoids and amphetamine etc.) within last 3 months. 7. History of hyperglycaemia (symptoms include nausea, vomiting,drowsiness, flushed dry skin, dry mouth, increased frequency of urination, thirst and loss of appetite as well as acetone breath). 8. History of diabetic ketoacidosis. 9. History of hypoglycaemia (symptoms include low pulse rate, watering of extremities, dizziness, weakness and sometimes fainting). 10. A history of neuropsychiatric diseases. 11. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the start of the study. 12. History or presence of asthma, urticaria or other allergic reactions. 13. History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour. 14. History or presence of cancer. 15. Consumption of xanthine-containing food and beverages (chocolates, tea, coffee or cola drinks) and tobacco products (Gutka or Pan masala) 48.00 hours prior to check-in. 16. Consumption of grapefruit, grapefruit juice/ products and poppy-containing food and beverages within at least 48.00 hours prior to every check-in. 17. History of difficulty with donating blood or difficulty in accessibility ofveins in left or right arm. 18. Donation of blood (1 unit) within 90 days prior to the first dose of the study drug or have blood loss, excluding volume drawn at sc
Exclusion criteria
Exclusion criteria: 1. Allergy or significant history of hypersensitivity or idiosyncratic reaction to E.coli-derived proteinsâ?? G-CSF or any other excipients in the particular product. 2. Cardiovascular, pulmonary, hepatic, renal, hematological, endocrinal, gastrointestinal, immunologic, dermatologic, neurological or psychiatric disease. 3. Having systolic blood pressure 130 mmHg, diastolic blood pressure 88 mmHg and pulse rate 100 4. Subjects who have been on an unusual diet (for whatever reason, less than 200 kilocalories (kcal) and more than 3000 kcal during the four weeks preceding the study 5. Use of drugs which may potentiate the release of neutrophilsâ?? such as lithiumâ?? in the previous 30 days before the study. 6. Female subjects who are currently breast feeding or pregnant or post menopausal (by history or as evidenced by hormonal results)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate equivalence of PK and PD characteristics of G-CSF of Biogenomics and Neupogen® after multiple SC injections in healthy adult human volunteers.Timepoint: PK-18 PD ANC-16 and CD34-5 | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the safety profile and local tolerance of G-CSF of BGL and Neupogen® after multiple SC injections in healthy adult human volunteersTimepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactDr Chandrashekhar Bolmall MD
BioGenomics Limited
Outcome results
None listed